Engineer II, QA

Joining Oxoid Remel Microbiology means becoming part of a team dedicated to making a meaningful difference in healthcare, food safety, and pharmaceutical manufacturing. Our products and solutions support accurate disease identification, targeted treatment, and the quality and reliability of microbiology testing around the world.

With a long-standing reputation for scientific excellence, quality, and innovation, we are committed to delivering products that meet the highest standards of performance and regulatory compliance.

As a QA Specialist, Quality Notifications, you'll play an important role in maintaining product quality, investigating customer concerns, and ensuring compliance with established quality systems and regulatory requirements.

You’ll work closely with Quality, Manufacturing, Technical Services, and cross-functional teams to investigate product issues, identify root causes, implement corrective actions, and support continuous improvement initiatives.

The QA Specialist, Quality Notifications is responsible for supporting quality assurance activities related to customer complaints, product investigations, quality notifications, and regulatory compliance.

This role involves conducting scientific and technical investigations, reviewing quality documentation, evaluating product performance, and communicating investigation findings to internal stakeholders and customers.

The ideal candidate brings a strong scientific foundation, excellent analytical and problem‑solving skills, attention to detail, and the ability to work collaboratively in a regulated environment.

• Lead internal quality investigations, including product evaluations and process reviews, to identify root causes of quality concerns.
• Investigate customer complaints and product performance issues, ensuring timely and thorough resolution.
• Partner with cross-functional teams to identify, implement, and monitor appropriate corrective actions.
• Apply structured problem‑solving techniques to investigate deviations, product failures, and quality‑related concerns.
• Support continuous improvement initiatives designed to strengthen product quality and operational effectiveness.

• Ensure quality activities comply with applicable regulatory requirements, including 21 CFR Part 820, ISO 13485, and other relevant international standards.
• Support the development, implementation, maintenance, and monitoring of Quality Management System procedures.
• Review Device History Records (DHRs), processing records, and other quality documentation to ensure accuracy, completeness, and compliance.
• Maintain accurate investigation records, quality documentation, and supporting data in accordance with established procedures.
• Identify potential compliance risks and collaborate with appropriate stakeholders to address concerns.

• Conduct microbiological product performance testing using ATCC reference organisms and established laboratory procedures.
• Evaluate microbiological testing results to support product investigations and customer complaint resolution.
• Collaborate with laboratory and technical teams to assess product performance and identify potential quality concerns.
• Maintain accurate testing documentation and communicate findings to relevant stakeholders.

• Prepare clear, accurate, and professional written responses to customer quality notifications, complaints, and product inquiries.
• Collaborate with customers, Technical Services, and internal teams to investigate and resolve product-related concerns.
• Provide technical guidance and support regarding product…